Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption, 54385 [2020-19256]
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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices
procurement-service-contractinventories. GSA has posted its FY 2016
and FY 2017 inventory analyses and its
planned analyses of FY 2018 and FY
2019 actions at the following location:
https://www.gsa.gov/gsasci.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1064]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d)
Submit written comments
(including recommendations) on the
collection of information by October 1,
2020.
OMB Control Number 0910–0277—
Extension
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0277. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
[FR Doc. 2020–19297 Filed 8–31–20; 8:45 am]
Notice.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
54385
Under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 343–1(b)), States may
petition FDA for exemption from
Federal preemption of State food
labeling and standard-of-identity
requirements. Section 100.1(d) (21 CFR
100.1(d)) sets forth the information a
State is required to submit in such a
petition. The information required
under § 100.1(d) enables FDA to
determine whether the State food
labeling or standard-of-identity
requirement satisfies the criteria of
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
Description of Respondents: The
respondents to this collection of
information are State and local
governments who regulate food labeling
and standards of identity.
In the Federal Register of May 22,
2020 (85 FR 31190), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.1(d) ................................................................................
1
1
1
40
40
jbell on DSKJLSW7X2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
we have received one new petition for
exemption from preemption; therefore,
we estimate that one or fewer petitions
will be submitted annually.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2020–19256 Filed 8–31–20; 8:45 am]
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
BILLING CODE 4164–01–Ps
VerDate Sep<11>2014
20:01 Aug 31, 2020
Jkt 250001
Food and Drug Administration
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00043
Fmt 4703
Sfmt 4703
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the proposed
extension of the collection of
information concerning requirements
relating to FDA’s Adverse Experience
Reporting System (FAERS) for licensed
biological products, and general records
associated with the manufacture and
distribution of biological products.
Submit either electronic or
written comments on the collection of
information by November 2, 2020.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
ADDRESSES:
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Page 54385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19256]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1064]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Petitions for
Exemption From Preemption
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 1, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0277. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
State Petitions for Exemption From Preemption--21 CFR 100.1(d)
OMB Control Number 0910-0277--Extension
Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption
from Federal preemption of State food labeling and standard-of-identity
requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the
information a State is required to submit in such a petition. The
information required under Sec. 100.1(d) enables FDA to determine
whether the State food labeling or standard-of-identity requirement
satisfies the criteria of section 403A(b) of the FD&C Act for granting
exemption from Federal preemption.
Description of Respondents: The respondents to this collection of
information are State and local governments who regulate food labeling
and standards of identity.
In the Federal Register of May 22, 2020 (85 FR 31190), we published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1(d)........................................................... 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for Sec. 100.1(d) is minimal because
petitions for exemption from preemption are seldom submitted by States.
In the last 3 years, we have received one new petition for exemption
from preemption; therefore, we estimate that one or fewer petitions
will be submitted annually.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19256 Filed 8-31-20; 8:45 am]
BILLING CODE 4164-01-Ps
